Current partner codePEPTIDESDE
NCT02274740·Phase 2·INTERVENTIONAL

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Status

Terminated

Phase

Phase 2

Enrollment

2

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation. The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity. The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.

Full detailed description

Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).

Interventions

Treatment arms and agents.

DRUG

LIXISENATIDE AVE0010

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

metformin

Pharmaceutical form:tablet Route of administration: oral

Timeline

From registration to results.

  1. First posted

    Oct 24, 2014

  2. Study start

    Apr 2015

  3. Primary completion

    Aug 2015

  4. Study completion

    Aug 2015

  5. Results posted

    Not reported

  6. Registry updated

    Jan 30, 2017

Outcomes

What the study measures.

Primary outcomes

Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)

Time frame · After 10 weeks of treatment

Secondary outcomes

Change from baseline in plasma triglyceride

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in plasma cholesterol

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in APO B48

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in free fatty acid levels

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in lipoprotein distribution

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in LDL oxidation

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in postprandial plasma glucose

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in insulin

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in C-peptide

Time frame · 2 days after the basal test and after 10 weeks of treatment

Change from baseline in low grade inflammation (cytokines and stress oxidative markers)

Time frame · 2 days after the basal test and after 10 weeks of treatment

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion criteria: Male and female patients, 18-70 years of age. Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index \[BMI\] \>30 kg/m\^2) and the following other abnormalities: * Abdominal obesity (waist circumference \>102 cm in men and \>88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001). * Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals \[such as 6.5%\] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease). * Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol \<300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia). * Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol \<40 mg/dL in men and \<50 mg/dL in women). Written informed consent. Exclusion criteria: Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone \[TSH\] \>5 mU/L with clinical symptoms of hypothyroidism). Hepatic disease (Aspartate Aminotransferase \[ASAT\] or Alanine Aminotransferase \[ALAT\] \>2 times the upper limit of normal). Renal disease (serum creatinine \>1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment. History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides \>600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.